Effective Date: 01/08/97
Title: Section 16.25 - Misadministrations

16.25 Misadministrations. (a) A medical misadministration shall be the administration of:

(1) A radiopharmaceutical or radiation from a source other than the one ordered;

(2) A radiopharmaceutical or radiation to the wrong person;

(3) A radiopharmaceutical or radiation by a route of administration or to a part of the body other than that intended by the ordering physician;

(4) An activity of a radiopharmaceutical for diagnostic purposes that differs from the activity ordered by more than 50 percent;

(5) An activity of a radiopharmaceutical for therapeutic purposes that differs from the activity ordered by more than 10 percent;

(6) A therapeutic radiation dose from any source other than a radiopharmaceutical or brachytherapy source such that errors in computation, calibration, time of exposure, treatment geometry or equipment malfunction result in a calculated total treatment dose differing from the final total treatment dose ordered by more than 10 percent; or

(7) A therapeutic radiation dose from a brachytherapy source such that errors in computation, calibration, treatment time, source activity, source placement or equipment malfunction result in a calculated total treatment dose differing from the final total treatment dose ordered by more than 10 percent; or

(8) A therapeutic radiation dose in any fraction of a fractionated treatment such that the administered dose in the individual treatment or fraction differs from the dose ordered for that individual treatment or fraction by more than 50 percent, except when the administered dose is lower than the dose ordered by more than 50 percent due to machine interruption, or due to patient inability or decision to not finish the treatment.

(b) Records and Reports of Misadministrations.

(1) Diagnostic misadministrations.

(i) Records of misadministrations as defined in subdivision (a) of this section which involve diagnostic procedures, and the corrective actions taken pursuant to subparagraph (ix) of paragraph (1) of subdivision (a) of section 16.23, shall be retained for three (3) years; and

(ii) If such a misadministration results in a dose to the patient exceeding 5 rem to the whole body or 50 rem to any individual organ, or the administration of iodine-131 or iodine-125 in the form of iodide, and in a quantity greater than 30 microcuries, the licensee or registrant shall notify the department in writing within 15 days and make and retain a record pursuant to paragraph (3) of this subdivision.

(2) Therapy misadministrations.

(i) When a misadministration described in paragraphs (5), (6), or (7) of subdivision (a) of this section, in which the percentage of error is equal to or less than 20 per cent is discovered the licensee or registrant shall immediately investigate the cause and take corrective action; and

(a) The licensee shall make and retain a record of all therapy misadministrations described in this subparagraph. The record shall contain all the information called for in paragraph (3) of this subdivision and shall be retained for six years.

(ii) When a therapy misadministration described in paragraphs (1), (2), (3) or (8) of subdivision (a) of this section is discovered; or when a misadministration described in paragraphs (5), (6) or (7) of subdivision (a) of this section in which the percentage of error is greater than 20 per cent is discovered; the licensee or registrant shall notify the department by telephone. The licensee or registrant shall also notify the referring physician of the affected patient and the patient, of any therapy misadministration described in this subparagraph, with the exception of misadministrations described in paragraphs (a)(1) and (8) of this section. When it is not medically advisable to give such information to the patient the information shall be made available to the patient's responsible relative or guardian on the patient's behalf. These notifications must be made within 24 hours after the misadministration is discovered. If the referring physician, patient, or the patient's responsible relative or guardian can not be reached within 24 hours, the licensee or registrant shall notify them as soon as practicable. It is not required that the patient be notified without first consulting the referring physician; however, medical care for the patient shall not be delayed because of this.

(iii) Within 7 days after an initial therapy misadministration report, the licensee or registrant shall send a written report to the department. The written report must contain the name of the licensee or registrant; the information called for in paragraph (3) of this subdivision; and whether the licensee or registrant notified the patient or the patient's responsible relative or guardian. A separate report is not required when an incident report containing all the aforesaid information is submitted to the department pursuant to Part 405 of this Title. (3) Each licensee or registrant shall maintain a record of each reportable misadministration for six years. The record must contain the names of all individuals involved in the event (including the treating physician, allied health personnel, the patient, and the patient's referring physician), the patient's social security number or identification number if one has been assigned, a brief description of the event, the effect on the patient, and actions taken to prevent recurrence.

(4) Within seven days after an initial therapy misadministration report made pursuant to subparagraph (ii) of paragraph (2) of this subdivision, the licensee or registrant shall provide the patient a written report with a copy to the patient's referring physician. The report shall contain a brief description of the event, the effect on the patient including any change in the patient's health status which resulted or could result from the misadministration, and recommendations for the appropriate course of treatment or follow-up. If it is not medically advisable to give such information to the patient, the report shall be made available to the patient's responsible relative or guardian on the patient's behalf and documented in the patient's treatment record.




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